Respiratory promotion apparatus

Abstract

A respiration promotion device (1) for coordinately stimulating two phrenic nerves at the neck of a patient in order to actuate the phrenic muscle of the patient comprises a first field generator (21), a second field generator (21) and a support structure (3). The first field generator (21) is configured to generate a first spatial field and can be positioned at the patient in order to stimulate a first phrenic nerve of two phrenic nerves of the patient by means of the first spatial field. The second field generator (22) is configured to generate a second spatial field and can be positioned at the patient in order to stimulate a second phrenic nerve of the two phrenic nerves of the patient by means of the second spatial field. The support structure (3) has an arm holder (33), a first arm (31), and a second arm (32). A first arm (31) and a second arm (32) extend from the arm holder (33). A first field generator (21) is mounted to the first arm (31) and a second field generator (22) is mounted to the second arm (32). The support structure (3) is configured to position the arm holder (33) above or behind the head of the patient such that the first arm (31) and the second arm (32) extend on both sides along the head towards the neck of the patient.

Description

Technical Field

[0001] The present invention relates to a breathing facilitation device. The breathing facilitation device includes a first field generator configured to be positioned to stimulate a first phrenic nerve of a patient, a second field generator configured to stimulate a second phrenic nerve of the patient, and a support structure to which the first and second field generators are mounted so as to be operable to coordinately stimulate the two phrenic nerves at the patient's neck to actuate the patient's diaphragm. Background Art

[0002] In medicine, it is known that for many purposes, it is advantageous to actuate target tissue in a patient using stimulation via electromagnetic, electric, or magnetic fields. To achieve such actuation of tissue within a patient, it is known to stimulate the tissue directly or indirectly by stimulating specific parts of the nervous system. For example, a target tissue, such as muscle tissue, can be actuated by providing electrical pulses directly to muscle tissue or nerves associated with the muscle tissue.

[0003] In a hospital intensive care unit or other department, it may be desirable to actuate the diaphragm to assist in ventilating the patient (typically in conjunction with mechanical ventilation) to prevent the disadvantages of diaphragm failure. Results have shown that within the first 18-69 hours of mechanical ventilation, atrophy of the diaphragm muscle fibers occurs, and during this period, the cross-sectional area of ​​the muscle fibers decreases by more than 50%. Therefore, the goal is to repeatedly actuate the diaphragm while providing artificial or mechanical ventilation to the patient so that the function of the diaphragm can be maintained, or at least to actuate the diaphragm during the weaning period to support the effective recovery of independent respiratory function.

[0004] It is known that the diaphragm can be actuated by stimulating the two phrenic nerves, for example at the patient's neck. In this context, US2016 / 0310730 A1 describes a device for reducing ventilation-induced diaphragmatic deactivation in a patient receiving ventilatory support from a mechanical ventilator. The device comprises a first and a second type of electrode array comprising a plurality of electrodes configured to stimulate the patient's phrenic nerve. At least one controller identifies the type of electrode array and, based on the identified electrode type, generates a stimulation signal to stimulate the patient's phrenic nerve. Such electrode-based stimulation is not very reliable with movement or repositioning of the patient, and the feasible stimulation depth may be significantly limited by bone or fatty tissue. In addition, electrode stimulation has been reported to cause more pain to the patient than electromagnetic stimulation.

[0005] In one example, the electrode array is configured as a surface electrode array embedded in an adhesive electrode patch that is placed on each side of the patient's neck near the area where the phrenic nerve is located. Thus, the electrode arrays are electrically and mechanically coupled to the patient's skin independently of each other. As a result, the electrode array covers a portion of the patient's surface and may interfere with other applications required to treat the patient, such as endotracheal intubation. In the event that the electrode array needs to be removed and replaced at a later point in time, the system needs to be completely recalibrated based on the new position of the electrode array to avoid undesirable co-stimulation of the tissue surrounding the phrenic nerve.

[0006] In practice, electromagnetic stimulators are also used to actuate target tissues, which are based on the principle of electromagnetic induction. Strong current pulses (usually single-phase or biphasic current pulses) flow through the coil windings, generating a strong transient magnetic field. The current pulses cause a changing magnetic field, which changes, for example, according to the phase of the current pulse. The changing magnetic field induces a corresponding electric field, which in turn depolarizes the neuronal membrane, resulting in an action potential passing through one or more nerves. The coil windings are usually designed to generate an electric field distribution curve of an induced field, which usually has an electric field peak (an area with maximum electric field strength) or an electric field area that is stronger than other fields in other areas. Therefore, the electric field distribution curve can generate actuation pulses that are periodically effective at time intervals, and the electric field peaks or strong field areas can alternate with weak field areas in the distribution curve.

[0007] However, when two target nerves (such as two phrenic nerves) that are close to each other in the body should be stimulated simultaneously, the coil winding system in the current stimulators for electromagnetic stimulation has obvious limitations. For this purpose, decentralized coils have been designed to generate decentralized fields, which have been described, for example, in DE 10 2007 013531A1. However, two independent stimulator devices are usually required, the electromagnetic fields of which may interfere with each other, and physical constraints may not allow the coil windings of the two devices to be positioned in parallel to utilize a decentralized design. Especially in the neck area, longitudinally positioning the two coil windings at the neck will force the user to select a significantly smaller coil winding size because the chin and chest limit the space for placing the coils.

[0008] To address these shortcomings of known configurations in the prior art, WO 202 / 074453 A1 proposes providing a support structure coupled to a first field generator and a second field generator. The support structure and the first and second field generators each have a forward-facing surface configured to be positioned on a patient. Specifically, the first and second field generators are positioned on the patient's neck, where they are accessible to the phrenic nerve, and the support structure is positioned on the patient's sternum. The support structure is adjustable, allowing the position and orientation of the first and second field generators to be adjusted as needed. In particular, by varying the configuration of the support structure, the positions of the first and second field generators relative to the patient and relative to each other can be adjusted to suit the specific treatment requirements of a particular patient, for example by selecting different distances between the two field generators and the patient's body. Furthermore, the orientation of the first and second field generators relative to each other and the orientation of the field generators relative to the patient can be adjusted, for example by selecting different angular adjustments for the first and second field generators.

[0009] However, while prior art support structures allow for a relatively stable arrangement on the patient's body and allow for appropriate adjustment of the position and orientation of the field generator, positioning the support structure on the sternum may compromise access to the patient. For example, when, in addition to phrenic nerve stimulation, the patient is mechanically ventilated and / or a tracheotomy must be performed, the support structure also being in front of the patient may obstruct or lead to awkward situations. Furthermore, the wires of the field generator may also complicate the arrangement of all desired or beneficial therapeutic mechanisms applied to the patient. Furthermore, since all components in front of the patient may physically or operationally interfere with each other, optimal positioning of the field generator may be hindered or even impossible.

[0010] Therefore, there is a need for a breathing facilitation device that allows for effective stimulation of both phrenic nerves, overcomes spatial limitations, avoids co-stimulatory effects of tissues adjacent to the phrenic nerves, is easy to apply to the patient, and is convenient and painless for the patient. Summary of the Invention

[0011] According to the invention, this need is solved by a breathing facilitation device as defined by the features of independent claim 1. Preferred embodiments are subject matter of the dependent claims.

[0012] In particular, the present invention relates to a breathing facilitation device for coordinating the stimulation of two phrenic nerves at a patient's neck so as to actuate the patient's diaphragm. The breathing facilitation device includes a first field generator, a second field generator, and a support structure. The first field generator is configured to generate a first spatial field and can be positioned at the patient to stimulate the first phrenic nerve of the patient's two phrenic nerves with the aid of the first spatial field. The second field generator is configured to generate a second spatial field and can be positioned at the patient to stimulate the second phrenic nerve of the patient's two phrenic nerves with the aid of the second spatial field. The support structure has an arm holder, a first arm, and a second arm. The first arm and the second arm extend from the arm holder. The first field generator is mounted to the first arm, and the second field generator is mounted to the second arm. The support structure is configured to position the arm holder above or behind the patient's head so that the first arm and the second arm extend along the head toward the patient's neck on both sides of the head.

[0013] As used herein, the term "positioning" refers to both location and orientation. Changing the positioning of an element involves relocating the element, reorienting the element, or a combination thereof. If an element or component is positioned to do something, it is advantageously positioned and oriented to perform that function. For example, a field generator positioned to stimulate the phrenic nerve may be positioned and oriented so that the phrenic nerve is within the spatial field generated by the field generator.

[0014] The terms "positioned at the body" or similar "held at the body" respectively relate to being positioned and oriented at the body. With respect to the field generator, these terms may relate to physical contact with the patient's body, in particular with the patient's neck, or close contact with the patient's body. Therefore, the position and orientation of the field generator or its components may be predetermined or differentiated to be suitable for actuating the diaphragm by stimulating the phrenic nerves. In order to be configured to be positioned at an appropriate position, the field generator may be formed to be suitable for the corresponding positioning. For example, it may be formed corresponding to the patient's neck so that it can be conveniently positioned at the neck, for example for stimulating one of the phrenic nerves. Since the patient's diaphragm is intended to be actuated, for example for ventilation, indirect actuation may be induced by positioning the first and second field generators so that one or both phrenic nerves are located in the spatial field generated by the field generators, thereby stimulating the phrenic nerves.

[0015] The term "spatial field" as used herein relates to any field which allows stimulation of the patient's phrenic nerve. It may in particular relate to an electric field or an electromagnetic field.

[0016] The spatial field can be configured to have a target shape. This target shape can be achieved by providing a locally constrained target electric field or electromagnetic field, for example, an electric field or electromagnetic field with a peak. It can be suitable for acting in a target area, which is the area of ​​the phrenic nerve that will be stimulated by the spatial fields of the first and second field generators, and the stimulation can be achieved, for example, by the peak (focal area) of the spatial field. The target shape can generally be any shape of the spatial field or its components that allows for effective stimulation of the phrenic nerve while minimizing other undesirable co-stimulatory effects of surrounding, above or nearby tissues or nerves. The peak shape is such an example because it maximizes the effect within the focal area and minimizes the effect outside the focal area.

[0017] To generate a spatial field, the field generator may include a coil design or coil unit. Thus, the term "coil design" may include or include at least two coil turns, or at least one conical or otherwise curved or convex coil, or at least one cylindrical or otherwise non-flat coil, or at least one small coil, i.e., a coil small enough to generate a sharp electromagnetic field, such as a coil with a diameter of less than 9 cm.

[0018] By configuring the support structure so that the arm holder can be positioned above or behind the patient's head, the two arms can in particular extend from the arm holder to the neck from both sides of the face. This arrangement allows preventing any parts of the breathing assistance device from being arranged in front of the patient. In particular, the front of the patient's neck as well as the mouth and nose can remain accessible or free. Thus, space limitations can be overcome and a sophisticated and ingenious / precise stimulation of the two phrenic nerves can be achieved. In addition, co-stimulatory effects of tissues near the phrenic nerves can be avoided and the application of the device is particularly simple, convenient and painless for the patient.

[0019] The support structure may be configured to flexibly adjust the position of the field generators. Thus, the first and second field generators may be positioned independently of each other relative to their respective phrenic nerves.

[0020] In particular, the first arm and the second arm are preferably manually adjustable relative to the arm holder to individually position the first field generator and the second field generator at a target location on the patient's neck. The term "target location" as used herein relates to the position and orientation of the first or second field generator suitable for stimulating the associated phrenic nerve in the patient's neck. In particular, at the target location, the respective field generator can generate a spatial field that reaches the associated phrenic nerve, which is advantageously achieved in a specific manner to prevent undesirable stimulation of other tissues in the patient's neck. As such, the device can be conveniently individualized to the respective patient, thereby specifically and effectively stimulating the phrenic nerve.

[0021] The breathing facilitation device preferably includes a locking mechanism for locking the first arm and the second arm in a target position. Like this, the support structure can be fixed to the conditions of a single patient, and the device can be conveniently maintained in a personalized configuration.

[0022] Thus, the locking mechanism comprises a first lever element located at the first arm for operating the locking mechanism relative to the first arm, and a second lever element located at the second arm for operating the locking mechanism relative to the second arm. By having two arms with levers, the individual arms can be individually adjusted and locked in their respective target positions.

[0023] Therefore, the locking mechanism is preferably configured to allow adjustment of the first arm when the first lever element is actuated, to prevent adjustment of the first arm when the first lever element is not actuated, to allow adjustment of the second arm when the second lever element is actuated, and to prevent adjustment of the second arm when the second lever element is not actuated. With respect to the first and second lever elements, the term "actuation" may refer to pressing or pushing a lever element or a portion thereof. This allows for particularly efficient and convenient adjustment of the support structure, and more specifically, adjustment of the arms of the support structure.

[0024] The locking mechanism preferably comprises a first tensioning device that locks / blocks the first arm in a target position when tensioned, and a second tensioning device that locks / blocks the second arm in a target position when tensioned. Such tensioning elements allow the arms of the support structure to be securely locked / blocked from changing.

[0025] Therefore, the first tensioning device preferably includes a first elastic member that blocks / locks / stops the first arm in the target position when tensioned, and the second tensioning device preferably includes a second elastic member that blocks / locks / stops the second arm in the target position when tensioned. In this way, the locking mechanism can be in a tensioned state and locked / blocked in an inactive or non-actuated state.

[0026] Actuation of the first lever element preferably releases the first elastic member of the first tensioning device, and actuation of the second lever element preferably releases the second elastic member of the second tensioning device.

[0027] Preferably, the first arm, the second arm, and the arm holder are configured such that the lengths of the first arm and the second arm are adjustable. When a locking mechanism is provided, such length adjustment can be limited to a state where the locking mechanism is not blocked. By having length-adjustable arms, the support structure can be effectively adjusted to accommodate different patient sizes.

[0028] Preferably, the first arm and the second arm each include a forearm portion, an intermediate arm portion, a rear arm portion, a front joint member connecting the forearm portion to the intermediate arm portion, and a rear joint member connecting the intermediate arm portion to the rear arm portion. This embodiment of the two joints of the arm allows sufficient flexibility to be provided to accurately adjust the arm. Similarly, this embodiment of the two joints can also provide relatively high robustness when locking a specific configuration / blocking its change. Each of the first arm and the second arm preferably includes less than six joint members. By limiting the maximum number of joint members of each arm, the force required to block the change / lock and / or unblock the change / unlock a single arm can be kept within a range that can be manually manipulated by most users. In other words, it is prevented that the force applied to block the change and / or unblock the change is too large.

[0029] Therefore, the support structure preferably comprises two moving members, each moving member connecting one of the rear arm parts of the first arm and the second arm to the arm holder.Such moving members allow the length of the arms to be adjusted individually, which is beneficial for adjusting the arms.

[0030] Each of the front and rear joint members preferably comprises a ball and socket joint.Such a ball and socket joint can provide advantageous flexibility and robustness in a relatively simple structure.

[0031] Preferably, the support structure comprises a main body portion and a bracket, wherein the arm holder is mounted to the main body portion, and wherein the main body portion is mounted to the bracket. With the aid of the bracket, the device can be securely positioned in a desired location. The main body portion, in turn, allows for the arm holder to be properly positioned so that the arms can be advantageously extended and properly arranged.

[0032] Therefore, the angle between the arm holder and the main body portion is adjustable. Like this, the inclination of the arm holder and therefore the inclination of the arm can be adjusted as required.

[0033] To achieve proper adjustment of the angle, the support structure preferably includes a hinge member connecting the arm holder to the body portion.

[0034] The body portion is releasably mounted to the support so that the support can be conveniently placed at the target location in a single step and then, once the support is securely positioned, the body portion can be positioned.

[0035] Preferably, the support comprises a head plate for receiving the patient's head and a beam member extending from the head plate. In particular, when the head plate is arranged in its target position, the beam member may extend upward from the head plate. With this configuration, the support can be securely held in place by the patient's head.

[0036] Therefore, preferably, the main body portion is height-adjustably mounted to the beam member of the support.As such, the given circumstances of an individual patient can be taken into account when adjusting or configuring the respiratory facilitation device.

[0037] The support preferably has at least one wing element that can be deployed outward from the side of the head plate. Advantageously, the support has two wing elements that are configured to be deployed in opposite directions. This at least one wing element allows for increased stability of the support when placed in the target position.

[0038] Preferably, the breathing facilitation device comprises a control unit configured to operate the first field generator to stimulate a first phrenic nerve of the patient, and to operate the second field generator to stimulate a second phrenic nerve of the patient.

[0039] Therefore, the support structure preferably comprises a first control button located at a first arm of the support structure and a second control button located at a second arm of the support structure, wherein the first control button and the second control button interact / interface / interact / communicate with the control unit such that actuating the first control button and / or the second control button provides a control signal to the control unit. The control buttons may be buttons, touch sensors or the like. Such a configuration allows verification whether the position of the individual field generators is suitable for stimulating the corresponding phrenic nerve. In particular, by applying a single stimulation pulse, it may be tested whether the field generators induce an appropriate response and, for example, once such a response is identified, adjustment of the arm may be prevented.

[0040] Preferably, the support structure is equipped with a data storage device configured to collect data regarding the operation of the first and second field generators. Such a data storage device allows for the collection of data regarding the patient's treatment. At a certain stage or at the end of treatment, a healthcare professional can evaluate the stimulation induced and the therapeutic effect achieved.

[0041] Therefore, the data on the operation of the first field generator and the second field generator preferably include any one of duration or intensity, or a combination thereof. In particular, the operation duration and field intensity during treatment may be key parameters to be assessed by medical workers. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The breathing facilitation device according to the present invention is described in more detail below by means of exemplary embodiments and with reference to the accompanying drawings, in which:

[0043] Figure 1 shows a front view of an embodiment of a breathing facilitation device according to the present invention;

[0044] Figure 2 Shown Figure 1 A side view of a breathing facilitation device;

[0045] Figure 3 Shown Figure 1 Rear view of the breathing facilitation device;

[0046] Figure 4 Shown Figure 1 A top view of a breathing facilitation device;

[0047] Figure 5 Shown Figure 1 A perspective view of a breathing facilitation device; and

[0048] Figure 6 Shown Figure 1 A cross-sectional view of a breathing facilitation device. DETAILED DESCRIPTION

[0049] In the following description, certain terminology is used for convenience and is not intended to limit the present invention. The terms "right," "left," "upward," "downward," "below," and "upper" refer to directions in the drawings. The terms used include the terms expressly mentioned, their derivatives, and terms of similar meaning. Similarly, spatially relative terms such as "below," "beneath," "below," "above," "upper," "proximal," and "distal" may be used to describe the relationship of one element or feature to another element or feature as shown in the drawings. These spatially relative terms are intended to encompass different positions and orientations of the device in use or operation, in addition to the positions and orientations depicted in the drawings. For example, if the device in the drawings is turned over, an element described as "below" or "beneath" another element or feature would then be oriented "above" or "above" the other element or feature. Thus, the exemplary term "below" encompasses both above and below positions and orientations. The device may be oriented in other ways (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein should be interpreted accordingly. Similarly, descriptions of movement along and about various axes encompass various specific device positions and orientations.

[0050] To avoid repetition in the drawings and the description of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. The omission of an aspect from the description or drawings does not mean that the aspect is missing from the embodiments that include the aspect. Instead, the aspect may be omitted for the sake of clarity and to avoid a lengthy description. In this context, the following applies to the remainder of this specification: if a drawing contains reference numerals that are not described in the directly related part of the description for the sake of clarity, reference may be made to the previous or subsequent parts of the description. In addition, for reasons of clarity, if reference symbols are not provided for all features of a component in a drawing, reference is made to other drawings showing the same component. Similar reference numerals in two or more drawings represent the same or similar elements.

[0051] Figure 1A front view of an embodiment of a breathing facilitation device 1 according to the present invention is shown. The breathing facilitation device 1 is configured to coordinately stimulate two phrenic nerves at the patient's neck in order to actuate the patient's diaphragm.

[0052] The breathing facilitation device 1 has a pair of field generators 2, including a first coil unit 21 as a coil design structure of a first field generator configured to generate a first spatial field, and a second coil unit 22 as a coil design structure of a second field generator configured to generate a second spatial field. The first coil design structure, in particular its first coil unit 21, is designed to be positioned at a patient to stimulate the first of the two phrenic nerves with the aid of the first spatial field. Similarly, the second field generator, in particular its second coil unit 22, is designed to be positioned at a patient to stimulate the second of the two phrenic nerves with the aid of the second spatial field. The first field generator includes a first power and data line 23, and the second field generator includes a second power and data line 24.

[0053] The breathing facilitation device also includes a supporting structure 3, which has an arm holder 33, a first arm 31 extending from the arm holder 33, and a second arm 32 extending from the arm holder 33. The first arm 31 has a first forearm portion 311 equipped with a first control button 381, a first middle arm portion 312, and a first rear arm portion 313. The first coil unit 21 is fixedly mounted to the first forearm portion 311. The first forearm portion 311 is connected to the first middle arm portion 312 via a first front ball joint 314 as a front joint member, and the first middle arm portion 312 is connected to the first rear arm portion 313 via a first rear ball joint 315 as a rear joint member. The first rear arm portion 313 is mounted to the left side end of the arm holder 33 in an adjustable manner in length.

[0054] The second arm 32 is more or less a mirror image of the first arm 31. It includes a second front arm portion 321 equipped with a second control button 382, ​​a second middle arm portion 322, and a second rear arm portion 323. The second coil unit 22 is fixedly mounted to the second front arm portion 321. The second front arm portion 321 is connected to the second middle arm portion 322 via a second front ball joint 324, which serves as a front joint member, and the second middle arm portion 322 is connected to the second rear arm portion 323 via a second rear ball joint 325, which serves as a rear joint member. The second rear arm portion 323 is mounted to the right end of the arm holder 33 in an adjustable length.

[0055] The support structure 3 also includes a main body portion 34 that is releasably mounted to a bracket 35. The main body portion 34 is connected to the first coil unit 21 via a first power and data line 23, and is connected to the second coil unit 22 via a second power and data line 24. The bracket 35 has a beam member 351 equipped with a height adjustment switch 354, a flat head plate 352, and two wing elements 353. The beam member 351 extends upward from the head plate 352, and the two wing elements 353 extend to the left and right from either side of the head plate 352, respectively.

[0056] The breathing facilitation device 1 further comprises a locking mechanism 4. The locking mechanism 4 has a first lever element 41 arranged at the first forearm portion 311 and a second lever element 42 arranged at the second forearm portion 321 .

[0057] exist Figure 2 , the breathing facilitation device 1 is shown from the side. Thus, it can be seen that the beam member 351 is slightly curved and forms a seat for the patient's head together with the head plate 352 when the patient is lying. In fact, the correct positioning of the patient's head on the head plate 352 enables a stable and safe arrangement of the breathing facilitation device 1. Thus, the arm holder 33 is located above the head of the lying patient, and the first and second arms 31, 32 extend along the head on both sides toward the patient's neck. Then, the first coil unit 21 can be appropriately positioned on the right side of the neck so that the phrenic nerve on the right side can be stimulated, and the second coil unit 22 can be appropriately positioned on the left side of the neck so that the phrenic nerve on the left side can be stimulated.

[0058] The beam member 351 has two parts, thereby allowing height adjustment. In particular, by switching the height adjustment switch 354 to the on position, the two parts of the beam member 351 can be moved upward and downward relative to each other. Once the height adjustment switch 354 is switched back to the on position, the two parts of the beam member 351 can be moved upward and downward relative to each other. Figure 2 In their substantially closed position shown, the two parts are blocked from each other and the height of the beam member 351 is set.

[0059] In order to properly adjust the angle of the arm holder 33 and the arms 31, 32 and the coil units 21, 22, the arm holder 33 is mounted to the main body 34 by a hinge member 36. In particular, the hinge member 36 includes a hinge unlocking control button 361, which is pressed to release the hinge member 36 so that the arm holder 33 can rotate freely within a predetermined range relative to the main body 34. By releasing the hinge unlocking control button 361 again, the hinge member 36 is locked in the corresponding position. Like this, the hinge member 36 is configured to allow the angle between the main body 34 and the arm holder 33 to be flexibly and patient-specifically adjusted.

[0060] If you can Figure 2 In particular Figure 3As can be seen in the figure, the main body 34 is equipped with a control unit connector 37. With the help of the control unit connector 37, the coil units 21, 22 and the components of the support structure 3 can be connected to the control unit (not visible in the figure) of the breathing facilitation device 1. For example, the control unit provides power and defines the intensity and course of operation of the coil units 21, 22. In this way, various complex therapeutic stimulations can be applied.

[0061] The main body 34 is equipped with a data storage device (not visible in the figure). The data storage device is configured to collect data regarding the operation of the coil units 21 and 22, such as the amount of field propagation, field strength, duration, etc. This allows analysis of the specific therapy being applied to the patient. In particular, the data storage device can be used to monitor and evaluate the use and therapeutic application of the breathing facilitation device 1.

[0062] Figure 4 FIG2 shows a top view of the respiratory facilitation device 1. It can be seen that the wing members 353 of the bracket 35 extend from both sides of the head plate 352 to the left and right sides of the patient's head, respectively. In this way, the contact surface of the head plate 352 between the respiratory facilitation device 1 and the structure on which it is positioned can be widened, thereby increasing the stability of the entire respiratory facilitation device 1.

[0063] Figure 5 A perspective view of the respiratory facilitation device 1 is shown. The wing elements 353 are pivotable relative to the head plate 352 so that they can be adjusted by folding inwards or outwards to adjust to a given situation / condition at which the respiratory facilitation device 1 is to be positioned. When not needed, the wing elements 353 can be fully pivoted into the head plate 352.

[0064] To tailor the design to the patient's needs, the arms 31 and 32 can be manually adjusted relative to the arm holder 33 to position the first coil unit 21 and the second coil unit 22 at the desired locations on the patient's neck, effectively stimulating the phrenic nerve. More specifically, a healthcare professional can use both hands to hold the two arms 31 and 32 of the support structure at the first forearm portion 311 and the second forearm portion 321. This allows the first lever element 41 and / or the second lever element 42 to be pressed or actuated, releasing or disengaging the locking mechanism 4. In this position of the locking mechanism 4, the first arm 31 and the second arm 32 can be freely positioned using the degrees of freedom provided by the front joint members 314 and 324 and the rear joint members 315 and 325, respectively. Furthermore, the lengths of the arms 31 and 32 can be adjusted by sliding them relative to each other in or out of the arm holder 33. In this manner, the coil units 21 and 22 can be precisely and intricately positioned on the patient's neck.

[0065] At the same time, i.e. without releasing the arms 31, 32, the medical worker can approach the first control button 381 and / or the second control button 382 with his thumb. When one of the control buttons 381, 382 is pressed, a signal is transmitted to the control unit, which in turn activates the associated first or second coil unit 21, 22 to generate a field that stimulates the corresponding phrenic nerve. The medical worker can determine whether the patient has responded appropriately to the stimulation or whether the associated coil unit 21, 22 must be repositioned. Once the coil units 21, 22 are correctly positioned, the medical worker stops pressing or activating the first and second lever elements 41, 42, which causes the locking mechanism to prevent any further changes in the shape of the arms 31, 32. In this way, a separate configuration of the support structure 3 can be set for the patient, and the arms 31, 32 are blocked in this target position.

[0066] Figure 6 A cross-sectional view of the arms 31, 32 of the support structure 3 is shown so that the components of the locking mechanism 4 are visible. The first rear arm portion 313 of the first arm 31 includes a first moving member 316, which is received by a corresponding recessed formation of the arm holder 33. Similarly, the second rear arm portion 323 of the second arm 32 includes a second moving member 326, which is received by a corresponding recessed formation of the arm holder 33. Each of the first front joint member 314, the first rear joint member 315, the second front joint member 324, and the second rear joint member 325 is implemented as a ball joint.

[0067] The locking mechanism 4 includes a first tensioning device 43 having a first tensioning wire 432 and a first spring 431 as a first elastic member. The first spring 431 is coupled to the first tensioning wire 432 and is pre-tensioned, so that when the first lever element 41 is not actuated, tension acts on the first tensioning wire 432. In this state, the first front joint member 314, the first rear joint member 315, and the first movable member 316 are fixed, so that the length, position, and orientation of the first arm 31 are locked / prevented from changing. To adjust the first arm 31, the first lever element 41 is actuated, which causes the first spring 431 to deform against its spring force. In this manner, the first tensioning wire 432 is released, and the first arm can freely rotate about its joint members 314, 315 and can be adjusted along its movable member 316.

[0068] Similar to the first tensioning device 43, the locking mechanism 4 also includes a second tensioning device 44 having a second tensioning wire 442 and a second spring 441 as a second elastic member. The second spring 441 is coupled to the second tensioning wire 442 and pre-tensioned, such that tension acts on the second tensioning wire 442 when the second lever element 42 is not actuated. In this state, the second front joint member 324, the second rear joint member 325, and the second movable member 326 are fixed, locking / preventing changes in the length, position, and orientation of the second arm 32. To adjust the second arm 32, the second lever element 42 is actuated, which causes the second spring 441 to deform against its spring force. In this manner, the second tensioning wire 442 is released, and the second arm can freely rotate about its joint members 324, 325 and be adjusted along its movable member 326.

[0069] As shown in the figure, the support structure 3 is configured to position the arm holder 33 above or behind the patient's head so that the first arm 31 and the second arm 32 extend along the head toward the patient's neck on both sides. In addition, with the first and second arms 31, 32 having a portion connected by a ball joint, movable relative to the arm holder 33 and equipped with a locking mechanism 4, the coil units 21, 22 can be moved in all degrees of freedom to be appropriately positioned on the patient's neck to effectively stimulate the phrenic nerve. When in the target position, the arms 31, 32 can be prevented from changing / locked, allowing the breathing facilitation device to be set to the patient's individual condition.

[0070] This specification and the drawings illustrating various aspects and embodiments of the invention should not be construed as limiting the claims defining the protected invention. In other words, although the invention has been shown and described in detail in the drawings and the preceding description, such illustrations and descriptions should be considered illustrative or exemplary rather than restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this specification and claims. In some cases, well-known circuits, structures, and techniques are not shown in detail so as not to obscure the present invention. Therefore, it should be understood that changes and modifications may be made by one of ordinary skill in the art within the scope and spirit of the following claims. In particular, the present invention encompasses other embodiments having any combination of the features of the different embodiments described above and below.

[0071] The present disclosure also encompasses all other features shown in the drawings, even though they may not have been individually described in the preceding or following description. Furthermore, individual alternatives of the embodiments and their features described in the drawings and description may be disclaimed from the subject matter of the present invention or from the disclosed subject matter. The present disclosure encompasses subject matter consisting of the features defined in the claims or exemplary embodiments, as well as subject matter containing said features.

[0072] Furthermore, in the claims, the term "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may perform the functions of multiple features recited in the claims. The mere fact that specific measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used advantageously. The terms "substantially / approximately", "about", "approximately" etc. in conjunction with an attribute or value particularly also explicitly define the attribute or explicitly define the value, respectively. The term "approximately" in the context of a given numerical value or range refers to a value or range, for example, within 20%, within 10%, within 5% or within 2% of the given value or range. Components described as coupled or connected may be directly coupled, electrically or mechanically, or they may be indirectly coupled via one or more intermediate components. Any figure marks in the claims should not be interpreted as limiting the scope of protection.

Claims

1. A breathing facilitation device (1) for coordinating the stimulation of two phrenic nerves at a patient's neck so as to actuate the patient's diaphragm, the breathing facilitation device comprising: A first field generator (21) configured to generate a first spatial field and configured to be positioned at a patient to stimulate a first phrenic nerve of two phrenic nerves of the patient with the aid of the first spatial field; a second field generator (22) configured to generate a second spatial field and configured to be positioned at the patient to stimulate a second phrenic nerve of the patient's two phrenic nerves with the aid of the second spatial field; and A support structure (3) having an arm holder (33), a first arm (31) and a second arm (32), wherein the first arm (31) and the second arm (32) extend from the arm holder (33), wherein the first field generator (21) is mounted to the first arm (31), the second field generator (22) is mounted to the second arm (32), and The support structure (3) is configured to position the arm holder (33) above and / or behind the patient's head so that the first arm (31) and the second arm (32) extend along the head on both sides toward the patient's neck.

2. A breathing facilitation device (1) according to claim 1, wherein: The first arm (31) and the second arm (32) can be manually adjusted relative to the arm holder (33) to independently position the first field generator (21) and the second field generator (22) at a target location on the patient's neck.

3. The breathing facilitation device (1) according to claim 2, comprising a locking mechanism (4), which is used to block the first arm (31) and the second arm (32) in a target position.

4. A breathing facilitation device (1) according to claim 3, wherein: The locking mechanism (4) comprises: a first lever element (41) located at the first arm (31) for operating the locking mechanism (4) relative to the first arm (31); and a second lever element (42) located at the second arm (32) for operating the locking mechanism (4) relative to the second arm (32).

5. A breathing facilitation device (1) according to claim 4, wherein: The locking mechanism (4) is configured to allow the first arm (31) to be adjusted when the first lever element (41) is actuated, to prevent the first arm (31) from being adjusted when the first lever element (41) is not actuated, to allow the second arm (32) to be adjusted when the second lever element (42) is actuated, and to prevent the second arm (32) from being adjusted when the second lever element (42) is not actuated.

6. A breathing facilitation device (1) according to any one of claims 3 to 5, wherein: The locking mechanism (4) comprises: a first tensioning device (43) which stops the first arm (31) at a target position when tensioned; and a second tensioning device (44) which stops the second arm (32) at a target position when tensioned.

7. A breathing facilitation device (1) according to claim 6, wherein: The first tensioning device (43) includes a first elastic member (431) for stopping the first arm (31) at a target position when tensioned, and the second tensioning device (44) includes a second elastic member (441) for stopping the second arm (32) at a target position when tensioned.

8. A breathing facilitation device (1) according to claims 5 and 7, wherein: Actuation of the first lever element (41) releases the first elastic member (431) of the first tensioning device (43), and actuation of the second lever element (42) releases the second elastic member (441) of the second tensioning device (44).

9. A breathing facilitation device (1) according to any one of claims 2 to 8, wherein: The first arm (31), the second arm (32) and the arm holder (33) are configured such that the length of the first arm (31) and the length of the second arm (32) are adjustable.

10. A breathing facilitation device (1) according to any one of claims 2 to 9, wherein: Each of the first arm (31) and the second arm (32) includes a front arm portion (311, 321), an intermediate arm portion (312, 322), a rear arm portion (313, 323), a front joint member (314, 324) connecting the front arm portion (311, 321) to the intermediate arm portion (312, 322), and a rear joint member (315, 325) connecting the intermediate arm portion (312, 322) to the rear arm portion (313, 323).

11. A breathing facilitation device (1) according to claims 9 and 10, wherein: The support structure (3) comprises two moving members (316, 326) each connecting one of the rear arm parts (313, 323) of the first arm (31) and the second arm (32) to the arm holder (33).

12. A breathing facilitation device (1) according to claim 10 or 11, wherein: Each of the front joint member (314, 324) and the rear joint member (315, 325) includes a ball joint.

13. A breathing facilitation device (1) according to any one of claims 10 to 12, wherein: Each of the first arm (31) and the second arm (32) includes less than six joint members (314, 315, 324, 325).

14. A breathing facilitation device (1) according to any one of the preceding claims, wherein: The support structure (3) comprises a main body portion (34) and a bracket (35), wherein the arm holder (33) is mounted to the main body portion (34), and wherein the main body portion (34) is mounted to the bracket (35).

15. A breathing facilitation device (1) according to claim 14, wherein: The angle between the arm holder (33) and the body portion (34) is adjustable.

16. A breathing facilitation device (1) according to claim 14 or 15, wherein: The support structure (3) includes a hinge member (36) connecting the arm holder (33) to the body portion (34).

17. A breathing facilitation device (1) according to any one of claims 14 to 16, wherein: The body portion (34) is releasably mounted to the bracket (35).

18. A breathing facilitation device (1) according to any one of claims 14 to 17, wherein: The support (35) includes a head plate (352) configured to accommodate a patient's head and a beam member (351) extending from the head plate (352).

19. A breathing facilitation device (1) according to claim 18, wherein: The main body portion (34) is height-adjustably mounted to the beam member (351) of the bracket (35).

20. A breathing facilitation device (1) according to claim 18 or 19, wherein: The support (35) has at least one wing element (353) which is arranged to be deployable outward from a side of the head plate (352).

21. A breathing facilitation device (1) according to any of the preceding claims, comprising a control unit, which is configured to operate the first field generator (21) to stimulate the patient's first phrenic nerve, and to operate the second field generator (22) to stimulate the patient's second phrenic nerve.

22. A breathing facilitation device (1) according to claim 21, wherein The support structure (3) comprises a first control button (381) located at a first arm (31) of the support structure (3) and a second control button (382) located at a second arm (32) of the support structure (3), wherein the first control button (381) and the second control button (382) are interconnected with the control unit so that actuation of the first control button (381) and / or the second control button (382) provides a control signal to the control unit.

23. A breathing facilitation device (1) according to any one of the preceding claims, wherein: The support structure (3) is provided with a data storage configured to collect data regarding the operation of the first field generator (21) and the second field generator (22).

24. A breathing facilitation device (1) according to claim 23, wherein: The data regarding the operation of the first field generator (21) and the second field generator (22) includes any one of duration, intensity, and a combination thereof.

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